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Effect of Using Barrier Devices for Intubation in COVID-19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412226
Recruitment Status : Completed
First Posted : June 2, 2020
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
ASIM ENES ÖZBEK, Derince Training and Research Hospital

Tracking Information
First Submitted Date May 31, 2020
First Posted Date June 2, 2020
Last Update Posted Date December 4, 2020
Actual Study Start Date June 10, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 31, 2020)
First pass success [ Time Frame: 2 minutes ]
Comparison of the first pass success rates for each method that were mentioned in the 'Detailed Description' of the study.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 31, 2020)
  • Time to endotracheal intubation [ Time Frame: 2 minutes ]
    The mean time to successful endotracheal intubation for each method that were mentioned in the 'Detailed Description' of the study.
  • Difficulty level of accessing the equipment [ Time Frame: 2 minutes ]
    Grading the difficulty of accessing the equipment on a 5-point Likert scale for each method that were mentioned in the 'Detailed Description' of the study.
  • Difficulty level of inserting the endotracheal tube into the glottis [ Time Frame: 2 minutes ]
    Grading the difficulty of inserting the endotracheal tube into the glottis on a 5-point Likert scale for each method that were mentioned in the 'Detailed Description' of the study.
  • Clarity of the view of the patient's face [ Time Frame: 2 minutes ]
    Grading the clarity of the view of the patient's face on a 5-point Likert scale for each method that were mentioned in the 'Detailed Description' of the study.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Using Barrier Devices for Intubation in COVID-19 Patients
Official Title Effect of Using Barrier Devices for Intubation in COVID-19 Patients: Randomized, Prospective, Manikin Study
Brief Summary The aim of this study is to compare the impact of using the aerosol box and transparent sheet as an adjunct to conventional personal protective equipment on endotracheal intubation of COVID-19 patients. The effect of the head of the bed elevation will also be evaluated during the mentioned simulated scenarios.
Detailed Description

This is a randomized, prospective, manikin simulation study. Emergency medicine specialists will be participated in the study. Participants will be randomly assigned into 6 groups with a 1:1:1:1:1:1 allocation following simple randomization procedures by a program generating online random numbers. 13 participants will be recruited to the study.

Operators who will intubate the manikin will use following methods: (1) conventional personal protective equipment (PPE) with placing the manikin in the supine position. (2) aerosol box as an adjunct to PPE with placing the manikin in the supine position. (3) transparent sheet as an adjunct to PPE with placing the manikin in the supine position. (4) conventional personal protective equipment (PPE) with placing the manikin in the 30 degree the head of the bed elevated position. (5) aerosol box as an adjunct to PPE with placing the manikin in the 30 degree the head of the bed elevated position. (6) transparent sheet as an adjunct to PPE with placing the manikin in the 30 degree the head of the bed elevated position.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population includes emergency medicine specialists who wants to participate to the study.
Condition
  • Intubation, Intratracheal
  • COVID-19
Intervention
  • Device: aerosol box
    The aerosol box is a barrier that protects the staff against the aerosols during the aerosol generating procedures like endotracheal intubation. It is a transparent cube that covers the patient's head during the endotracheal intubation. Operator can intubate the patient through the two holes for arms.
  • Device: transparent sheet
    The transparent sheet is a barrier that protects the staff against the aerosols during the aerosol generating procedures like endotracheal intubation. It is a transparent cover that covers the patient's head and body during the endotracheal intubation. Operator can intubate the patient through the space under the cover
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 31, 2020)
13
Original Estimated Enrollment Same as current
Actual Study Completion Date June 30, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participants who want to participate the study

Exclusion Criteria:

  • Participants who do not want to participate the study
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04412226
Other Study ID Numbers 2020/56
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party ASIM ENES ÖZBEK, Derince Training and Research Hospital
Study Sponsor Derince Training and Research Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Derince Training and Research Hospital
Verification Date December 2020